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Pharm Chapter 2
Chapter 2: Drug Development and Ethical Considerations
| Question | Answer |
|---|---|
| What are the 3 core ethical principles developed to protect humans involved in research studies? | Respect for persons Beneficence Justice |
| What does the ethical principle "respect for persons" mean? | "Patients should treated as persons capable of making decisions in their own best interests" "Those with diminished decision-making capacity are entitled to protection" Alternatives should be given as well as their risks |
| _______, or "the right to self-determination", is integral to the ethical principle "respect for persons" | Autonomy |
| Due to their right of ____, patients can refuse any and all treatments except when the decision poses a threat to others—such as with tuberculosis, when taking medications is legally mandated. | Right of Autonomy (allows patients to refuse treatment or bow out of a research study at any time without penalty) |
| The 1947 Nuremberg Code established what principle? | The Code established *informed consent* |
| What is "informed consent"? | - It is a mutual sharing of information, a process of communication -respect for the patient -active patient involvement in their care -respect's patient's self-determination |
| T/F: "It is the role of the health care provider, not the nurse, to explain the study to the patient and what is expected of the patient and to respond to questions from the patient" | True, it is NOT the nurse's responsibility to explain the study |
| What is the criteria of the patient (2) and the document (2) the patient signs to acknowledge their consent? | Patient: Alert and Able to Comprehend Consent Form: (1) written at or below an 8th grade reading level (2) contains words with less than three syllables |
| What is the definition of "beneficence", the second core ethical principle? | Beneficence is "the duty to protect research subjects from harm" |
| ________ involves the nurse "ensuring the risks and possible benefits from participating in a research study are clearly defined and ensuring the benefits are greater than the risk" | Beneficence (the duty to protect patients and participants from harm) |
| Due to ______, "the physical, psychological, and social risks towards the participants must be identified and weighed against the benefits." | the Risk-Benefit Ratio |
| T/F: "No matter how noble the intentions, the calculation of risks and benefits by the researcher cannot be totally accurate or comprehensive" | True |
| ________ "requires that the selection of research subjects be fair" | Justice (the 3rd core ethical principle) |
| What is an example of "Justice" in research? | "Research must be conducted so that the distribution of benefits and burdens is equitable (i.e., research subjects reflect all social classes and racial and ethnic groups)" |
| What happens during Phase 1 of Human Research Trials? | Researchers test a new drug or treatment in a small group of healthy people (20-80); evaluate its *safety*, determine a safe dosage range, and identify side effects |
| What happens during Phase 2 of Human Research Trials? | "The drug or treatment is given to a larger group of normal people (100-300) to test its *effectiveness* |
| What happens during Phase 3 of Human Research Trials? | "The drug or treatment is given to large groups (over 1,000) to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug or treatment to be used safely." |
| What happens during Phase 4 of Human Research Trials? | The drug has been approved for sale by the FDA; additional tests are done to study long-term effects, as well as optimal and additional uses for the drug |
| What is the Prescription Drug User Fee Act of 1992? | -est. to reduce delays in the FDA approval process -provided the FDA with funds to expedite the review process from 2.5 yrs to 1 year |
| Through the preclinical trials with animals, drug manufacturers are able to determine the drug's _________ | genotoxicity- "the ability of a compound to damage genetic information in a cell" |
| What is the difference between a independent variable and an dependent variable? | independent variable (treatment, such as with a drug or placebo) dependent variable (outcome, such as side effects) |
| _______ variables are factors that might interfere with the study results | Intervening (extraneous) variables |
| What are examples of intervening (extraneous) variables that might interfere with the results of a study? | "age, sex, weight, disease state, diet, and the subject’s social environment" |
| What are the two roles of a nurse in clinical research? | (1) responsible for patient safety (2) responsible for integrity of research protocol (confidentiality) |
| When was the American Nurses Association (ANA) Code of Ethics originally adopted? When was it revised? | Code of Ethics: adopted in 1950; revised in 2015 |
| "The _____ group in drug trials is the group that receives the drug being tested" | Experimental group (gets the legitimate drug) |
| "The ____ group in drug trials may receive no drug; a different drug; a placebo (pharmacologically inert substance); or the same drug with a different dose, route, or frequency of administration" | Control group (Conned into taking placebo) |
| The _______________ "was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.” | American Nurses Association (ANA) Code of Ethics (1950,2015) |
| "America’s first law to regulate drugs was the ________, which prohibited the sale of misbranded and adulterated drugs but did not address drug effectiveness and safety." | Food and Drug Act of 1906 |
| The ______ Amendment of 1912 "prohibited false therapeutic claims on drug labels" | The Shirley Amendment (1912); came after a cough syrup contained morphine and killed many infants |
| This Act, established in 1938, required FDA to ensure that all drugs are tested for harmful effects; it also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects" | The Federal Food, Drug, and Cosmetic Act (1938) |
| This Amendment from 1951 "distinguished between drugs that could be sold with or without prescription by a licensed health care provider." | The Durham-Humphrey Amendment (1951) |
| This Act (1962) "resulted from the widely publicized thalidomide tragedy of the 1950s"; "tightened controls on drug safety, especially experimental drugs, and required that adverse reactions and contraindications be labeled" | "Kefauver-Harris Amendment to the 1938 Act" (1962) |
| This act included: (1) promotion of drug education and research into the prevention and treatment of drug dependence; (2) strengthening of enforcement authority; (3) est. rehab facilities; and (4) designation of categories for controlled substances | The Comprehensive Drug Abuse Prevention and Control Act (1970): designed to remedy the escalating problem of drug abuse |
| What type of drugs are part of the Schedule I controlled substances? | Heroin, LSD, MDMA, peyote; drugs that are NOT approved for medical use AND have HIGH abuse potential |
| What type of drugs are part of the Schedule II controlled substances? | oxycodone, fentanyl, cocaine, methamphetamine and hydrocodone + acetaminophen |
| "Substances in this schedule have a high potential for abuse that may lead to severe psychological or physical dependence." | Schedule II substances (cocaine, fentanyl, oxycodone) |
| "Examples of Schedule _____ drugs include products containing less than 90 mg of codeine per dosage unit (acetaminophen with codeine), ketamine, anabolic steroids, and testosterone." | Schedule III drugs (acetaminophen plus codeine) |
| "Examples of Schedule ____ substances include alprazolam, carisoprodol, diazepam, lorazepam, zolpidem, and tramadol." | Schedule IV substances (tramadol, lorazepam, diazepam, alprazolam) |
| "Examples of Schedule _______ drugs include cough preparations containing not more than 200 mg of codeine or per 100 mL (codeine/guaifenesin), diphenoxylate/atropine, difenoxin/atropine, and pregabalin." | Schedule V drugs (guaifenesin + codeine = Robitussin AC) |
| "The ____ Act of 1996 protects health insurance coverage for workers who change or lose their jobs and sets the standard for the privacy of individually identifiable health information" | Health Insurance Portability and Accountability Act (HIPAA) |
| The ______ Act of 2010 "include (1) quality, affordable health care for all Americans; (2) improved quality and efficiency of health care; (3) prevention of chronic disease and improved public health;" | Patient Protection and Affordable Care Act (2010) |
| This 2012 Act (1) collects fees from industry to fund reviews of drugs with the “breakthrough gene therapy” designation" (2) " Expedites devel. of innovative, safe, and effective products" (3) "Enhancing the safety of the global drug supply chain" | The Food and Drug Administration Safety and Innovation Act (2012) |
| What does the Nurse Practice Act pertain to? | It allows nurse practitioners to prescribe drugs to patients; also dictates how practicing nurses can administer drugs to their patients |
| What is "misfeasance"? | Negligence; giving the wrong drug or dose that results in the client's death; The action must not be against the law, and the person who performs the harmful act does not intend to hurt anyone. |
| What is "nonfeasance"? | Omission; omitting a drug dose that results in the client's death; Nonfeasance differs from malfeasance and misfeasance because it is the failure to act altogether. |
| What is "malfeasance"? | Intentional unethical to illegal actions and can include cases that cause physical harm to another person; walking past a patient who is calling for help and ignoring them, resulting in their death |
| Drug names: Chemical vs Generic vs Brand/Trade names | Chemical name describes the drug's chemical structure. Generic name: the official, *nonproprietary* name (accounts for 80% of all drug sales). Brand (trade) name: *proprietary* name chosen by the company and trademarked. |
| How are generic drug names written different from brand names? | Generic names are lowercase (furosemide) whereas brand names are *always* capitalized (Lasix) |
| What is the generic name for Advil, Medipren, Motrin, and Nuprin? | ibuprofen |
| What is the generic name for the propriety brand name Lunesta? | eszopiclone |
| "If the generic drug is found to be **_________** to the brand-name drug, the generic drug is considered **_______ ______** and is given an A rating" | "If the generic drug is found to be **bioequivalent** to the brand-name drug, the generic drug is considered **therapeutically equivalent** and is given an A rating" |
| "If there is less than a _____% variance in drug absorption, distribution, metabolism, and excretion, a generic drug is considered equivalent to the brand-name drug." | less than a 20% variance (generic name is "equivalent" to brand name drug) |
| According to the textbook, "Generic drugs have the same active ingredients as brand-name drugs but are usually less expensive." Why is that the case? | Generic drugs require less extensive testing; "these drugs were clinically tested for safety and efficacy by the pharmaceutical company that first formulated the drug" |
| What factors affect drug bioavailability (the % of the drug dose that reaches the systemic circulation)? (Hint: drugs administered intravenously have 100% bioavailability) | A drug's bioavailability is affected by: "varying inert fillers, binders, and excipients used to shape tablets and control how fast or slow the drug is released in the body", |
| T/F: "To maintain stable drug levels, patients should be cautioned not to change generic drug manufacturers" | True: because of possible variations in their (the drug's) action or in the patient’s response to them" **this is particularly true when patients are prescribed phenytoin or warfarin |
| What does the acronym SAFER (a mnemonic for the instructions that the FDA recommends before taking any medicine) stand for? | Speak up Ask questions Find the Facts Evaluate your choices Read labels |
| List the two examples of OTC (over-the-counter) drugs that require a driver's license and age varification | (1) Emergency contraception (SINNER!!!!) (2) pseudoephedrine (treat nasal and sinus congestion, Sudafed) |
| List (in order) the specific information that is required on all OTC drug labels | (1) Active ingredients + amount in each dosage unit (2) Purposes of drug (3) Uses (indications) for product (4) Warnings (5) Dosage instructions (when, how, how often) (6) Inactive ingredients |
| What are some of the risks of taking OTC drugs? | - many of these drugs are *potent* and can cause moderate to severe side effects -many contain the same active ingredients, potentially leading to overdose -self-diagnosis and self-prescribing = bad |
| What are the drug interactions or side effects of ibuprofen? | -can increase fluid retention, (worsen heart failure); -daily use may decrease the effectiveness of antihypertensive drugs -Ibuprofen has also been linked with cardiovascular events (myocardial infarction + strokes) |
| What are the drug interactions or side effects of acetaminophen? | -kidney disease, anemia and thrombocytopenia, myocardial infarction, stroke, and hypertension -toxic metabolites (cause liver damage) -allergic rxn's (anaphylaxis) or skin reactions (Stevens-Johnson Syndrome [SJS] or toxic epidermal necrolysis [TEN] |
| "Since 2011 the FDA has limited the dose of ____ to 325 mg when packaged in combination with other drugs" | acetaminophen (325 mg limit) |
| Some OTC cough medicine is combined with 2-4 drugs; what is the danger of this? | The cough medicine, which in itself is a concoction of several medications, may cause health problems when combined with a prescription medication |
| What are the drug interactions or side effects of aspirin? | -aspirin can trigger an acute asthma episode in patients with asthma -aspirin may act as a deregulator of leukotrienes (help prevent breathing problems) |
| Why is aspirin NOT recommended for children? | children with influenza symptoms or chickenpox who've taken aspirin have experienced Reye syndrome (rare disease, causes swelling in liver and brain) |
| "Patients with kidney disease should avoid _____, _____, and _____ because these can further decrease kidney function, especially with long-term use" | aspirin, acetaminophen, and ibuprofen |
| "Patients taking moderate to high doses of aspirin, ibuprofen, or naproxen concurrently with an oral anticoagulant may be at increased risk for _______." | Bleeding |
Created by:
agiitter
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